Clinical Trial: Telithromycin: in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adult Outpatients With COPD
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter, Multinational, Randomized, DB Controlled Study of the Efficacy & Safety of Oral Telithromycin 800 mg Once QD for 5 Days vs Azithromycin in the Treatment of Acute Exacerbation of
Brief Summary: Non-inferiority efficacy of telithromycin versus azithromycin
Detailed Summary:
Sponsor: Sanofi
Current Primary Outcome: Principal efficacy criterion: clinical outcome - Main secondary efficacy criteria: − Bacteriological response at TOC visit; − Time to relapse up to 6 months after inclusion. [ Time Frame: At TOC visit (Day 17-Day 21). ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Sanofi
Dates:
Date Received: October 1, 2007
Date Started: November 2002
Date Completion:
Last Updated: February 15, 2012
Last Verified: February 2012